Aerie Pharmaceuticals Initiates Netarsudil Ophthalmic Solution Phase 2 Clinical Trial in Japan Designed to Support Requirements for Future Regulatory Filing

DURHAM, N.C.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class therapies for the treatment of
patients with open-angle glaucoma, retinal diseases and other diseases
of the eye, today announced the commencement of patient dosing in its
Phase 2 clinical trial designed in accordance with the requirements of
Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) to support
potential regulatory submission of netarsudil ophthalmic solution
in Japan. Netarsudil ophthalmic solution 0.02% is known by the name
Rhopressa^® in the United States and is approved for the
reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension.

This Phase 2 trial is being conducted in Japan as a precursor to Phase 3
registration trials in that country. The prospective, double-masked,
multi-center, placebo-controlled, parallel group study is designed to
evaluate the IOP-reducing effect and safety of three concentrations of
netarsudil ophthalmic solution over a 28-day period. Entry criteria
include unmedicated baseline IOP ranges at 9:00 AM of 15 mmHg
(millimeters of mercury) to less than 35 mmHg for patients with
open-angle glaucoma, and 22 mmHg to less than 35 mmHg for patients with
ocular hypertension. A total of approximately 208 patients will be
randomized equally across four treatment arms: netarsudil ophthalmic
solution 0.01%, netarsudil ophthalmic solution 0.02%, netarsudil
ophthalmic solution 0.04%, and placebo, all administered once daily in
the evening.

As agreed with the PMDA, the design of this trial is consistent with
that of a recent Phase 2 pilot study conducted in a Japanese-American
population in the United States, with the addition of the netarsudil
ophthalmic solution 0.01% treatment arm to confirm the concentration of
netarsudil most suitable for this population. Studies of glaucoma in
Japan suggest that patients have baseline IOP that is generally lower
than those experienced by patients in the United States and Europe,
hence the IOP range in the netarsudil Japanese Phase 2 trials begins
lower, at 15 mmHg.

“Building upon the positive topline results of our pilot Phase 2 study,
we are very pleased to take this next step on the pathway toward a
regulatory filing in Japan for netarsudil ophthalmic solution,”
said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at
Aerie. “We anticipate completing enrollment in this study before the end
of 2019 and then preparing for a netarsudil Phase 3 program. We believe
there continues to be substantial unmet need for novel glaucoma
therapeutics in Japan, particularly medicines that are effective in
patients with low baseline intraocular pressures.”

Topline results of the Phase 2 pilot study in Japanese Americans were
announced in January 2019. In that study, netarsudil ophthalmic solution
0.02% reduced mean diurnal IOP by a range of 5.0 to 5.3 mmHg in patients
with an average baseline IOP of 18.3 mmHg. Netarsudil ophthalmic
solution 0.04% reduced mean diurnal IOP by a range of 5.2 to 6.6 mmHg in
patients with average baseline IOP of 20.2 mmHg. Both netarsudil arms
produced significantly greater IOP reduction than placebo at Day 28. The
safety findings were consistent with previous netarsudil trials.